K203836 is an FDA 510(k) clearance for the BOMEDENT Apex locator, WISMY Apex locator. This device is classified as a Locator, Root Apex.
Submitted by Changzhou Bomedent Medical Technology Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on March 30, 2021, 90 days after receiving the submission on December 30, 2020.
This device falls under the Dental FDA review panel.
| 510(k) Number | K203836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2020 |
| Decision Date | March 30, 2021 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LQY - Locator, Root Apex |
| Device Class | - |